Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Two (2) participants were recruited between Jan 2009 and March 2010 at Mayo Clinic. This trial was permanently closed in March 2010 due to funding issues. Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

No text entered.

Reporting Groups

Description

DC-APCC

Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Since only two participants were accrued, patient confidentiality prevents the reporting of these two participants.

Reporting Groups

Description

DC-APCC

Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.